Cleared Traditional

NO FLOSS FLOSSER (K854326) - FDA 510(k) Clearance

Class I Dental device.

K854326 · Rgm Assoc. · Dental device
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Apr 1986
Decision
177d
Days
Class 1
Risk

K854326 is an FDA 510(k) clearance for the NO FLOSS FLOSSER. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Rgm Assoc. (Los Altos, US). The FDA issued a Cleared decision on April 23, 1986 after a review of 177 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6865 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Rgm Assoc. devices

Submission Details

510(k) Number K854326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date April 23, 1986
Days to Decision 177 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 127d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JEQ Toothbrush, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6865
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.